Hemi-bridge and methods of manufacturing and using same

ABSTRACT

A method of closing a wound includes providing a first bridging portion comprising a first insert having at least one first eyelet, and a first upper layer of material at least partially disposed over the first insert, and a first lower layer of material disposed below the first insert, the first lower layer of material having an adhesive disposed on a first lower surface, wherein the first insert, the first upper layer and the first lower layer form three zones of different elasticity and stiffness than others of the zones.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 16/879,971, filedMay 21, 2020, which is a continuation-in-part of U.S. Non-Provisionalapplication Ser. No. 16/576,907, filed Sep. 20, 2019, which claimspriority to U.S. Provisional Application Ser. No. 62/876,849, filed Jul.22, 2019, and U.S. Provisional Application Ser. No. 62/836,341, filedApr. 19, 2019, the contents of which are hereby incorporated byreference in their entirety as if fully set forth herein.

FIELD OF THE DISCLOSURE

The present disclosure relates generally to wound closure and methodsand devices for improving same. More specifically, the presentdisclosure relates to a hemi-bridge device and methods for facilitatingwound closure using same.

BACKGROUND OF THE DISCLOSURE

Sutures are stitches used to close open wounds and/or surgical incisionsof a patient. A medical practitioner generally uses a needle with anattached thread to substantially sew two adjacent sections of skintogether to close the wound or incision. Surgical knots are often usedto secure the sutures and ensure proper healing. Sutures and surgicalknots contacting the skin can be inflammatory and/or become “ingrown”and actually impede healing of the wound or incision. Additionally,complications may arise if the suture is tied too tightly or tooloosely. Moreover, traditional techniques may leave unsightly “trackmarks.”

Closure may be difficult, especially in high-tension areas of the skin,such where skin overlies the shoulder, knee, angle of the mandible, etc.Wound eversion occurs when the two wound surfaces are horizontallyopposed into one another such that the closed incision is under notension and topographically lies in a plane above the resting horizontalskin plane. Wound closures with maximal eversion resist excessivewidening of the scar due to ongoing ambient stresses in the high-tensionarea during the wound healing and scar maturation processes. However,wound eversion can be technically difficult to achieve for less skilledoperator, and a device to facilitate this is desirable. Further, theremay be excessive tension on closures where an excisional defect ispresent in the skin. When suture is placed under excessive tension toclose such wounds, the suture itself can slice through the skin(“cheesewiring”).

Moreover, adhesive dressings of uniform elasticity impart shear force tothe skin, greatest at the point of the dressing farthest from the sourceof the tension, which increases the risk of blistering. There is a needfor an adhesive dressing of variable elasticity such that the elasticityat the end of the dressing farthest from the source of tension moveswith a skin-like elasticity and thus reduces the risk of blistering.

Thus, there exists a need for suture devices that improve upon andadvance the known suturing and dressing techniques.

SUMMARY OF THE DISCLOSURE

In at least some embodiments, a stress dispersing device having aplurality of zones including a first zone, a second zone and a thirdzone, includes a lower layer extending across each of the first zone,the second zone and the third zone, an upper layer disposed in the firstzone and the second zone, and an insert having at least one eyeletdisposed in the first zone, the insert being sandwiched between theupper layer and the lower layer.

In some embodiments, a stress dispersing device having a plurality ofzones including a first zone, a second zone, a third zone, a fourthzone, and a fifth zone includes a lower layer extending across each ofthe plurality of zones, an upper layer disposed in the first zone, thesecond zone, the fourth zone, and the fifth zone, and at least oneinsert having at least one eyelet disposed in the first zone and thefifth zone, the at least one insert being sandwiched between the upperlayer and the lower layer.

In at least some embodiments, a system includes a suture securing deviceincluding a pair of hemi-bridges, each of the pair of hemi-bridgeshaving a plurality of zones including a first zone, a second zone and athird zone, the hemi-bridges including (i) a lower layer extendingacross each of the first zone, the second zone and the third zone, (ii)an upper layer disposed in the first zone and the second zone, and (iii)an insert having at least one eyelet disposed in the first zone, theinsert being sandwiched between the upper layer and the lower layer; anda fastening element coupling the pair of hemi-bridges.

BRIEF DESCRIPTION OF THE DISCLOSURE

Various embodiments of the presently disclosed hemi-bridges aredisclosed herein with reference to the drawings, wherein:

FIG. 1 is schematic cross-sectional view of a hemi-bridge according toone embodiment of the present disclosure;

FIG. 2 is a schematic top view of the hemi-bridge of FIG. 1 ;

FIG. 3 is a schematic cross-sectional view showing a pair ofhemi-bridges being used to close a wound;

FIGS. 4A-F are schematic illustrations showing various suture patterns;

FIGS. 5A-C are alternative embodiments of a hemi-bridge having insertsof various shapes;

FIGS. 6-7 are schematic top and side views of variations of hemi-bridgeshaving interdigitation features;

FIGS. 8 and 9 are schematic illustrations showing side and top views ofa hemi-bridge according to yet another embodiment;

FIG. 10 is schematic top and side views of the insert of the hemi-bridgeof FIGS. 8 and 9 ;

FIG. 11 includes perspective top and bottom views of the hemi-bridge ofFIGS. 8 and 9 , and a third perspective exploded view of the componentsof the hemi-bridge;

FIG. 12 is a schematic illustration showing a pair of hemi-bridges beingused with one possible suture pattern to close a wound;

FIGS. 13A-B are schematic illustrations showing a side view of a flathemi-bridge, and a top view of the flat hemi-bridge according to yetanother embodiment;

FIGS. 13C-F are schematic top and side views showings several variationsof the flat hemi-bridge of FIGS. 13A-B;

FIGS. 14A-C are schematic illustrations showing the use of the flathemi-bridge device of FIGS. 13A-B;

FIG. 14D is an illustration of a finite element analysis showing stressprofiles of a wound closed with a hemi-bridge device, and a wound closedwithout a hemi-bridge device;

FIGS. 15A-C are schematic illustrations showing the use of the flathemi-bridge device with staples;

FIGS. 16A-B illustrate another example of using a flat hemi-bridgedevice of FIGS. 13A-B;

FIGS. 17A-G are schematic top view and sides views of other embodimentsof hemi-bridges having transitioning sections;

FIGS. 18A-C are schematic side and top views of another embodiment of ahemi-bridge having a waterproof coverings;

FIGS. 19A-D are schematic top views of several examples of eyeletarrangement on a hemi-bridge;

FIGS. 20A-F are schematic top views of several embodiments ofhemi-bridges having a plurality of digits, and suture patterns to beused therewith;

FIGS. 21A-B are schematic top and perspective views of a unibodyhemi-bridge having digits; and

FIGS. 22A-C are schematic top views of several examples of a hemi-bridgehaving slits or holes in a second zone.

Various embodiments of the present invention will now be described withreference to the appended drawings. It is to be appreciated that thesedrawings depict only some embodiments of the invention and are thereforenot to be considered limiting of its scope.

DETAILED DESCRIPTION

Despite the various improvements that have been made to wound closuredevices, conventional methods suffer from some shortcomings as discussedabove.

There therefore is a need for further improvements to the devices andmethods used to help facilitate proper and quicker healing of a wound.Among other advantages, the present disclosure may address one or moreof these needs.

FIG. 1 is schematic cross-sectional view of a hemi-bridge 100.Hemi-bridge 100 generally extends between a proximal end 102 and adistal end 104, the proximal end being relatively closer to the wound,and the distal end being relatively farther from the wound. Hemi-bridgemay include an insert 105 sandwiched between two layers of material. Asshown, the insert is sandwiched between two layers of material include alower layer 106, and an upper layer 108. In some variations, one or morewaterproof layers may be disposed above the upper or lower layers sothat a total of two, three, or four layers may be formed, not includingthe insert.

Insert 105 may be formed of a rigid material. In some examples, theinsert is formed of a thermoplastic material such as polypropylene,polyethylene terephthalate, polyethylene (LDPE and HDPE),polymethylmethacrylate, polyethylene terepthalate glycol (PTG) such as10 MIL or 20 MIL PETG or as low as 1 MIL PETG, polydimethyl siloxane,polyoxymethylene, polycarbonate, polyamide and nylon, polyvinylchloride, polyphenylene sulfide, acrylonitrilebutadienestyrene,polystyrene, polytetrafluoroethylene or polyurethane. Preferably thethermoplastic material may have a suitable melting temperatures. Insert105 may be formed of other suitable materials such as metals.

As shown, insert 105 may be stair-shaped, including a lower step 110, aninclined ramp 112 and an upper step 114, the inclined ramp connectingthe two steps together. Insert 105 may have a length of approximately5-20 mm, and preferably about 10 mm. Insert 105 may have a width that isapproximately 2-6 mm, and a thickness of approximately 0.025 to 2 mm,depending on the material chosen. For example, a 20 MIL PETG insert maybe 0.5 mm thick, a 10 MIL PETG insert may be 0.25 mm thick and a 1 MILPETG insert may be 0.025 mm thick. In at least some examples, the upperstep may be elevated by approximately 2 to 5 mm. In at least someexamples, the lower and upper steps are of a same length, orapproximately a same length. Insert 105 may have a generally constantsingle thickness along the lower step, the inclined ramp and the upperstep. As best shown in FIG. 2 , each of the upper and lower steps110,114 may include a respective eyelet 120,124 for receiving a suture.In at least some examples, the eyelets are circular and of a same sizeas shown. Alternatively, eyelets may be formed of other shapes, such asoval, rectangular, triangular, etc. Eyelets 120,124 may allow thehemi-bridge to be used with various suturing configurations includingsimple, pulley and vertical mattress configurations, as will bedescribed in more detail below. It will be understood that an insert mayinstead include only a single eyelet, or more than two eyelets (e.g.,three, four, five or more eyelets).

Insert 105 may be disposed on one end of the device, in this caseadjacent the proximal end 102, and may be substantially or entirelycovered by lower and upper layers 106,108. Lower and upper layers106,108 may be formed of rectangular strips of material, such as thosetypically used as a dressing. In some examples, the lower and upperlayers or strips are approximately 50 mm in length, and 5-25 mm inwidth. In at least some other examples, the lower layer is approximately80 mm in length, and approximately 30 mm in width. In some examples, thelower and upper layers have the same width as the insert or are slightlywider than the insert. In some examples, the lower and/or upper layersare substantially longer than they are wide (e.g., 2×, 3×, 4×, 5× or 6×longer than they are wide). This length to width ratio may provideadequate surface area of adhesion over which to spread the tension. Alonger upper and/or lower material may also reduce and/or eliminate thetilting effect of the insert's upper step falling over to contact thelower layer of material.

The upper and lower layers 106,108 may be formed of the same or similarmaterial, size and/or configuration. Alternatively, the upper and lowerlayer may share some characteristics or may be formed of a differentmaterial, size and/or configuration.

Lower layer 106 may be formed of a woven, or non-woven material. Oneexample of a suitable material is STERI-STRIP® reinforced adhesive skinclosures. In some examples, the lower layer includes a suitablenon-woven material that prevents the absorption of blood and/or fluids,such as a polyurethane material. In some examples, lower layer 106 mayhave an adhesive lower surface that will be in contact with the skin.Alternatively, both surfaces of the lower layer 106 may have anadhesive. The material of lower layer 106 may be isotropic (i.e., it hasequal elasticity in any direction along its plane). Alternatively, thematerial of lower layer 106 may be anisotropic (i.e., it has variableelasticity in at least two directions along its plane). For example, thelower layer 106 may have a first elasticity along its longitudinal axis,and a second elasticity perpendicular to its longitudinal axis, thefirst elasticity being greater than the second elasticity, or viceversa.

In some examples, lower layer 106 may be reinforced withlongitudinally-oriented polymer filaments or fiberglass strands (e.g.,filaments 130 in FIG. 2 ) that results in anisotropic characteristics sothat the material does not stretch along its longitudinal axis, but doesstretch in lateral directions. FIG. 2 shows one example of a hemi-bridgehaving an insert 105 disposed on a lower layer 106, the lower layerhaving longitudinally-oriented filaments 130. For the sake ofsimplicity, the upper layer is not shown. As shown in FIG. 2 , thefilaments may be located along only a portion of the length of the lowerlayer. Thus, filaments 130 may extend along the entire length of thelower layer, more than half of the length of the lower layer, half ofthe lower layer, or less than half of the length of the lower layer(e.g., the filaments may extend along 100%, 90%, 80%, 70%, 60%, 50%,40%, 30%, 20% or less of the length of the lower layer). Alternatively,lower layer 106 may include no filaments at all. That is, lower layermay be isotropic, or may be anisotropic without the use of filamentsthrough the use of other techniques. The lower layer may be isotropic atone end, and anisotropic at another end (e.g., it may include filamentsat the proximal end where the insert is disposed, and no filaments onthe opposite end). In some example, the lower layer may be selected toprevent or reduce the possibility of skin maceration.

Upper layer 108 may be formed of a woven, or non-woven material. In someexamples, the upper layer includes a suitable non-woven material thatprevents the absorption of blood and/or fluids. In some examples, upperlayer 108 may have an adhesive lower surface that will be in contactwith the insert or the lower layer. The material of upper layer 108 maybe isotropic (i.e., it has equal elasticity in any direction along itsplane). Alternatively, the material of upper layer 108 may beanisotropic (i.e., it has no stretch in at least one direction along itsplane).

In some example, upper layer 108 may also be reinforced withlongitudinally-oriented polymer filaments or fiberglass strands thatresults in anisotropic characteristics so that the material does nostretch along its longitudinal axis, but does stretch in lateraldirections. Filaments 130 may extend along the entire length of theupper layer, more than half of the length of the upper layer, half ofthe upper layer, or less than half of the length of the upper layer(e.g., 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20% or less).Alternatively, upper layer 108 may include no filaments at all. That is,upper layer may be isotropic, or may be anisotropic without the use offilaments. The upper layer may be isotropic at one end, and anisotropicat another end (e.g., it may include filaments at the proximal end wherethe insert is disposed making it inelastic or less elastic in alongitudinal direction, and no filaments on the opposite end making itmore elastic in the longitudinal direction).

By choosing the appropriate elasticity for the upper and/or lower layers(e.g., isotropic vs. anisotropic), an impedance mismatch between theskin and the lower layer of material may be lowered, reducing thepossibility of blister formation. Blister formation may result fromnon-yielding materials adherent to the skin as tension imparted to theskin creates shearing forces in the horizontal plane of the skin thatseparate layers of the skin from one another (e.g., separating theepidermis from the dermis). In some examples, the presence ofanisotropic segments that can mimic the elasticity of the underlyingskin at predefined locations within the upper and/or lower layer mayalleviate the shearing forces at certain positions. In some examples,the presence of isotropic segments at predefined locations within theupper and/or lower layer may alleviate the shearing forces at certainpositions. Additionally, filaments in the upper and/or lower layers mayserve to stabilize the insert to keep it upright, and prevent it fromtipping.

As previously noted, upper and lower layers may share some or all of thecharacteristics. For examples, the two layers may be formed of the samematerial, may have the same non-woven construction, may include the sametype of adhesive, may have the same elasticity profile, and/or the sameextent, direction, amount and/or orientation of filaments.

In use, a hemi-bridge 100 may be laid flat on the skin surface on bothsides of the wound, the lower layer of material contacting the skinsurface. The edge of the hemi-bridge 100 may be disposed at the edge ofthe wound, or may be set back from the wound by 2 to 5 mm. Preferably,an adhesive on the lower surface of the lower layer couples the lowerlayer to the skin. The stair-shaped insert 105 is disposed above thelower layer and covered by the upper layer. In at least some examples,two hemi-bridges 100 are used, the two bridges facing one another andbeing disposed on either side of a wound “W” (FIG. 3 ). A suture patternmay be used to gather the ends of the wound with the hemi-bridges.Details of the various patterns will be described below. However,generally, the hemi-bridges may be brought together such that the uppersteps of the two hemi-bridges come in contact with one another whengathered by the sutures. Alternatively, only a single pair ofhemi-bridges may be used. Multiple pairs of hemi-bridges (e.g., 4hemi-bridges) may also be used in some examples.

FIGS. 4A-C illustrate various suture patterns P1-P5 being used to gatherends of a wound using exemplary hemi-bridges. In FIG. 4A, afar-near-near-far pulley suture pattern P1 is formed with the suture. Inthis case, far refers to passing through an eyelet 120 on the lowerstep, while near refers to passing through an eyelet 124 on the upperstep, and the “far-near-near-far” refers to the sequence in which thesuture passes through these eyelets. In this and other examples, adotted line indicates that the suture is under the skin and/orhemi-bridge and cannot be seen from a top view. In FIG. 4B, afar-far-near-near vertical mattress suture pattern P2 is shown. In FIG.4C, two possible suture patterns P3,P4 are shown, the first being asimple interrupted near-near suture pattern P3, and the second being asimple interrupted far-far suture pattern P4. Finally, in FIGS. 4D-E,horizontal mattress suture patterns P5 are shown. In FIG. 4D, twohemi-bridges are disposed on either side of the wound, for a total offour hemi-bridges, each hemi-bridge being vertically aligned withanother hemi-bridge adjacent to it, and horizontally aligned with anopposing hemi-bridge opposite the wound. Instead of using multiplehemi-bridges on either side of the wound, a compound hemi-bridge may beformed as shown in FIG. 4E, the compound hemi-bridge having widenedupper and lower layers of material, and two or more inserts sandwichedbetween the layers (e.g., two, three, four, five or more inserts) andaligned with one another. Optional filaments are shown in thisconfiguration, the filaments being located on one or two sides of theeither the upper layer, the lower layer, or both.

Using any of the suture patterns described above, or other suitable one,a physician may apply tension to the suture of up to 10 or 20 Newtons,or between 5 and 30 Newtons, to gather the two ends of the woundtogether. The hemi-bridges, and specifically the inserts, may act toelevate the suture above the wound, and may allow the physician to applymore force than possible without the use of the hemi-bridges. Moreover,the use of device having a rigid insert as described may preventcheesewiring of a suture closing a wound under tension. For example, awound closed under 20 Newtons of force without the present devices wouldlikely suffer from cheesewiring of the suture through the skin. However,by using any of the present devices and techniques, the force of thesuture may be substantially borne by the insert, and then transmitted tothe entire area of the device, the relatively large surface area of thedevice being helpful in prevent injury or damage to the patient's skin.Additionally, elevation of the suture may reduce the likelihood of“track marks” on the patient's skin.

In some examples, the shape of the insert may be different. For example,FIG. 5A shows a hemi-bridge structure 500 a having a proximal end 502and a distal end 504, a wedge-shaped insert 505 a having a step andupper and lower layers of materials 506,508 sandwiching the insert. FIG.5B shows a hemi-bridge structure 500 b having a proximal end 502 and adistal end 504, a ramp-shaped insert 505 b and upper and lower layers ofmaterials 506,508 sandwiching the insert. Any of the inserts in FIGS.1-6 may be used to elevated the suture above the wound surface.

FIG. 5C shows another example in which two separate steps are formedinstead of a continuous hemi-bridge. Specifically, bridge 500 c includesa first step 150 a and a second step 150 b, the height of the first stepbeing greater than the height of the second step. Alternatively, thefirst and second steps 150 a, 150 b may be of a same height. Each stepmay include an eyelet as described above. The two steps are not directlyconnected to another, but are both sandwiched by upper and lower layersof material. In at least some examples, the upper and/or the lower layerof material includes sets of filaments 130 a, 130 b disposed adjacenteach of the steps, but the spacing between the two steps does notinclude such materials. One example of this embodiment in use is shownin FIG. 4F, in which bridge 500 c is being used in a pulley suturearrangement P6.

Additionally, the top step of the insert may have interdigitationincluding a series of spaced projections 606 and depressions 607 so thattwo opposing hemi-bridges 605 a, 605 b may mate together with theprojections and valleys of the two hemi-bridges interlocking with oneanother when the two components come together (FIG. 6 ). FIG. 7illustrates another example of interdigitation where the hemi-bridges705 a, 705 b include a high-low tooth configuration arranged to matewith one another and form a complete bridge.

To manufacture the hemi-bridges, a rigid or substantially rigid insertsuch as those described above (e.g., a thermoplastic insert) may besandwiched between upper and lower layers in a large sheet. Thecomponents may be die cut to the appropriate size, and holes may beformed in the insert to create eyelets. The assembly may be placed in aheated press, the press having a temperature that exceeds the meltingtemperature of the insert, but be below the safe temperature of theupper and lower layers. The heated press may also include an elevatedportion to create the step in the insert. In addition to forming thestep in the insert, the heated press may also reduce the presence ofsharp edges at the bottom of the hemi-bridge by curling the sides of thedevice upward to redirect lower edges away from the skin of the patient.After proper heating, the assembly may be removed and cooled. Thefinished device may then be used to close a wound as described above.Alternatively, the insert may be formed separately (via injectionmolding, 3D printing or other techniques) and later coupled to the upperand lower layers.

The suture securing devices, systems, and methods described herein maybe used to secure a suture and reduce or eliminate the likelihood that asuture may become inflamed, infected, ingrown, and/or reopened andincrease the length of time that the suture can remain in place, amongother purposes. Additionally, the devices disclosed herein may becapable of allowing a physician to apply a large force when tying asuture without damaging nearby tissue, and in some cases may be used toavoid the usage of skin grafts to close relatively large wounds.

FIG. 8 is schematic cross-sectional view of a hemi-bridge 800 accordingto yet another embodiment. Hemi-bridge 800 generally extends between aproximal end 802 and a distal end 804, the proximal end being relativelycloser to the wound, and the distal end being relatively farther fromthe wound. Hemi-bridge may include an insert 805 sandwiched between twolayers of material. Specifically, the two layers of material include alower layer 806, and an upper layer 808. Lower and upper layers 806,808may be coupled together via an adhesive where they are in contact.Additionally, insert 805 may be coupled via adhesive, or other suitablemeans, to the top of the lower layer 806 and/or the bottom of the upperlayer 808.

Insert 805 may be formed of any of the materials discussed above withreference to insert 105, such as various thermoplastics and/or metals,and lower and upper layers 806,808 may be formed of the same materialsas lower and upper layers 106,808. As shown, insert 805 may bestair-shaped and includes a lower step, an inclined ramp and an upperstep similar to the configuration of FIG. 1 . As best shown in FIG. 9 ,each of the upper and lower steps may include a respective eyelet820,824 for receiving a suture. In at least some examples, the eyeletsare circular and of a same size as shown, or may be in any of theconfigurations previously described.

Hemi-bridge 800 may be divided into three zones, z1,z2,z3. First zone z1may include insert 805 sandwiched between lower and upper layers806,808. Second zone z2 may include only the lower and upper layers806,808 without the insert 805. Third zone z3 may include only a singlematerial, such as lower layer 806. The three zones z1-z3 may formdifferential stiffness zones that become less stiff further from thewound edge (e.g., greatest stiffness at proximal end 802 and smalleststiffness at distal end 804). First zone z1 provides the greateststiffness, primarily due to the presence of the essentially inelasticinsert 805. Second zone z2 may be less stiff with its bi-layer ofnon-woven material (e.g., lower layer 806 and upper layer 808), whichmay be fused with an adhesive or coupled together in any suitablemanner. Third zone z3 may be the least stiff with a monolayer ofnon-woven material (e.g., only lower layer 806 or only upper layer 808)and may serve as the most reliable adhesive zone.

Without being bound by any particular theory, it is believed that in thevicinity of the wound (i.e., closer to first zone z1) will be exposed tomore fluid. All dressings have a tendency to lose adhesion with acertain distance of the edge of the dressing. For example, a 10 mmdressing may have 1-2 mm of loss of edge adhesion due to moisture, etc.Thus, after a few days, a 10 mm wide strip may really only have 6-8 mmof useful adhesion with further deterioration thereafter. Thus, having awider and longer third zone, z3, may provide much more width prior tolosing adhesion and will also tend to reduce shear through highercross-sectional surface area.

In some examples, insert 805 may be formed as a flat piece that is bentto include a step as previously discussed. In at least some examples,the step forms an angle θ of between 20 and 60 degrees. In at least someexamples, the angle θ is between 30 and 50 degrees. In at least someexamples, the angle θ is equal to or approximately 40 degrees as shownin FIG. 10 .

As shown in the perspective views, the lower and upper layers 806,808and the insert 805 may have a shape and a size that matches othercomponents adjacent thereto. For example, both the lower and upperlayers 806,808 may have a generally rectangular stepped-shape thatmatches the insert 805 at first zone z1. Both lower and upper layers806,808 may have a narrowed neck at second zone z2, and lower layer 806may have a wider and longer rectangular shape at third zone z3.

In at least some examples, the hemi-bridge has a total length ofapproximately 2 to 3 cm, or about 2.3 to 2.4 cm. Third zone z3 may havea length that is 40% to 50% of the total length of the hemi-bridge.First and second zones z1,z2 may be approximately equal in length, orfirst zone z1 may be slightly longer than second zone z2. Third zone z3may be the widest of the three zones, and may have a width of between0.5 and 0.6 cm. Second zone z2 may be the narrowest and may have a widthof between 0.3 and 0.35 cm. First zone z1 may be wider than second zonez2 and narrower than third zone z3 and may have a width of between 0.4and 0.5 cm. The surface area may be greatest in third zone z3 andsmallest in second zone z2. Insert 805 may have a thickness of between0.010 cm and 0.030 cm and specifically about 0.020 cm.

In at least some examples, two hemi-bridges 800 are used, the twobridges facing one another and being disposed on either side of a wound“W” (FIG. 12 ). A suture pattern may be used to gather the ends of thewound with the hemi-bridges using any of the suturing techniques andpatterns described above with reference to the other embodiments.However, generally, the hemi-bridges may be brought together such thatthe upper steps of the two hemi-bridges approach each other, or come incontact with one another when gathered by the sutures.

Although the hemi-bridges have been disclosed as having an insertincluding an upper step, a lower step and a connecting ramp, othervariations are possible. For example, instead of having an inclinationangle as previously described, the insert may be completely flat. Forexample, hemi-bridge 900 extends between ends 902,904 and includes aplanar insert 905 that is covered by lower layer 906 and upper layer 908(FIGS. 13A-B). It will be understood that in manufacturing the device,upper and lower layers of material may sandwich an insert and form aconfiguration similar to the flat configuration of FIGS. 13A-B. The flatsandwich of lower layer-insert-upper layer may be collectively die cutbefore thermoforming at a high temperature (e.g., 200 degrees F.) toform an inclined angle and any number of steps. It will be understoodthat the flat configuration may be used in certain applications, andthat other applications may require thermoforming to provide an angle of10, 20, 30, 40, 50 or 60 degrees. Thus, the angle of inclination may beformed as desired for a specific application.

Even without an inclination, the flat configuration of hemi-bridge 900may elevate a suture or other fastening element via insert 905 toachieve one or more of the advantages described above. In at least someexamples, the lower layer 906 is formed of a non-woven polyester with anadhesive backing, insert 905 is formed of PETG, and upper layer 908 isformed of polyethylene. In at least some examples, the lower layer 906may also partially or entirely include an elastic tape having variablethickness such as Microfoam tape made by 3M®, the tape being capable ofhaving variable elasticity due to the variable thickness. The non-wovenpolyester lower layer 906 may have the PETG insert adhered to its topsurface at one end, the inert having one or more (e.g., two) eyelets.Due to the layering of material, a stepped configuration having threezones, z1,z2,z3 is formed, first zone z1 having all three layers, secondzone z2 having two layers, and third zone z3 having only the lowerlayer.

As shown in FIG. 13B, third zone z3 may be the widest portion of thedevice 900 with only a single layer of stretchable and absorbentadhesive material. The material of lower layer may experience a highamount of strain under force, so an elastic material may be used toallow less shear force on the trailing edge, a common problem inadhesive dressings. Second zone z2 may be a narrowed central portion oftwo layers. In addition to the lower layer, the second zone may have apolyethylene upper layer 908 to resist blood and fluid from beingabsorbed into the dressing. The polyethylene layer may also providestrength and reinforcement for the narrow central zone. First zone z1may be the strongest and most rigid due to the presence of the insert905. Insert 905 may resist tearing under high tension (e.g., up to 20Nor 30N of force) and may also elevate the suture material above theskin.

First and second zones z1,z2 may allow blood to be wiped off the deviceand provide a stiff connection to third zone z3, where shear forces arereduced by the single layer of lower stiffness material. Thus, differentregions may be formed with increasing elasticity from first zone z1closer to the wound toward third zone z3 farthest from the wound. Thatis, first zone z1 may have the lowest elasticity, second zone z2 mayhave an intermediate elasticity, and third zone z3 may have the greatestelasticity. Conversely, first zone z1 may have the greatest stiffness,second zone z2 may have an intermediate stiffness that is less than thestiffness of first zone z1, and third zone z3 may have the loweststiffness compared to the other three zones. The device 900 alsoincreases in height as it gets closer to the wound to provide elevation.

Without being bound by any particular theory, it is the believed thatthe suture acts to not only apply tension to gather the wound, but alsoapplies a downward force on the rigid insert. This downward force ishelpful to keep a consistent contact of the adhesive of the lower layerwith the skin. Additionally, a planar rigid insert may evenly distributethis pressure on the skin, and the downward force may reduce thelikelihood of maceration.

FIGS. 13C-F are schematic top and side views showings several variationsof the flat hemi-bridge of FIGS. 13A-B. In FIG. 13C, a hemi-bridgedevice 900C is formed that is similar to that of FIGS. 13A-B, butexcludes the tailored or narrowed neck in second zone z2. Instead, thelower and upper layers present a continuous width that is present infirst and second zones z1,z2 as shown, while third zone z3 is wider thanboth.

In FIG. 13D, a hemi-bridge 900D includes the narrowed neck formed insecond zone z2, but the upper layer 908C partially extends over thewider portion of lower layer 906 as shown so that second zone z2 havingtwo layers of material is slightly longer than the embodiment of FIGS.13A-B. In this example, upper layer 908C may have three widths includinga first width adjacent the insert, a second width at the tailored neckand a third width at the wider region of the lower layer. It will beunderstood that the embodiments of FIGS. 13C and 13D may be combined sothat the upper layer only includes a constant first width adjacent theinsert and a majority of the second zone z2, and a second widthoverlying the wider region of the lower layer.

FIG. 13E illustrates yet another embodiment of a hemi-bridge 900E, thehemi-bridge having a lower layer 906, an insert 905 and an upper layer908 as described above. Hemi-bridge 900E further includes a coveringlayer 912, formed of a waterproof material, the covering layer 912 beingdisposed on and partially or fully extending over the upper layer 908.Covering layer 912 may be of the same length as upper layer 908 and maybe disposed in first zone z1, and extend into second zone z2 to provideadditional stiffness to second zone z2.

In FIG. 13F, yet another embodiment is shown, which is similar to thatof FIG. 13B, except that hemi-bridge 900F includes a rigid member 905Fembedded and/or affixed between the lower and upper layers, the rigidmember being configured and arranged so that the user can pass a sutureover or around it. In some examples, the rigid member is staple-shapedas shown, or curvilinear. Rigid member 905F may be formed of any of thematerials described herein for the inserts such as, for example,thermoplastics or metals. It will be understood that this feature may becombined with any of the embodiments described herein, and that therigid members may be substituted for the inserts described in any of thedisclosed embodiments.

In use, two hemi-bridge devices 900 may be laid flat on the skin surfaceon either side of the wound, the lower layer of the device contactingand being adhered the skin surface (FIG. 14A). The edge of thehemi-bridge 900 may be disposed at the edge of the wound W14, or may beset back from the wound W14 by 2 to 5 mm. A suture S14 may enter a firsteyelet of the first hemi-bridge, pierce the skin and traverse the woundthrough the underlying tissue, exiting the first eyelet of the secondhemi-bridge as shown in FIG. 14A. Suture S14 may be used to gather themargins of the wound and a knot may be tied (FIG. 14B). Generally, thehemi-bridge devices are disposed near the middle of the wound as shown,although different configurations are possible. With the center of thewound gathered (FIG. 14B), additional sutures S14′ may be used to gatheredges of the wound and completely close the wound (FIG. 14C).

FIG. 14D is an illustration of a finite element analysis showing stressprofiles of a wound closed with a hemi-bridge device (left image), and awound closed without a hemi-bridge device (right image). In a woundclosed with only sutures, stress is concentrated near the wound edge.The stress is greatest at the wound edge and decreases radially outwardfrom the wound edge. As shown, the use of a hemi-bridge device allowsfor stress to be dispersed over a larger area away from the wound in aprofile that mimics the perimeter of the device. Specifically, thehemi-bridge device substantially reduces or practically eliminatesstress at the wound edge with the greatest stress being experienced nearthe eyelet of the device. A substantial portion of the total is stressis distributed over the area of the hemi-bridge device.

It will be understood that other ways of using the hemi-bridge devicesare possible. For example, as shown in FIGS. 15A-C, surgical staples S15or clips may be used instead of sutures to close wound W15 and mayextend through any of the eyelets of the insert. Additionally,combinations of various kinds of fastening elements (e.g., sutures,clips, staples, etc.) may be used, and the eyelets of the device may beconfigured to accept any or all kinds of fastening elements.

In another example (FIG. 16A-B), hemi-bridge devices may be used toclose larger wounds W16. In this example, wound W16 may have missingunderlying tissue such that piercing and traversing the underlyingtissue is difficult or impossible. In such a case, a suspended sutureS16 may be used to gather tissue without traversing the underlyingtissue. In one example, skin may be missing below zone z1 of the device,but may be present in zones z2 and z3. In such a situation, a suture maynot pierce the skin adjacent first zone z1, but the hemi-bridge devicemay remain secured to the skin via zones z2 and z3 only.

FIG. 17A is a schematic top view of another embodiment of a hemi-bridge,and FIG. 17B is a side view of same. Generally, hemi-bridge 1000 extendsbetween proximal and distal ends 1002,1004 and includes a planar insert1005 disposed between lower layer 1006 and upper layer 1008. It will beunderstood that in manufacturing the device, upper and lower layers ofmaterial may sandwich the insert and form a configuration similar to theflat configuration of FIGS. 13A-B. It will be understood that the flatconfiguration may be used in certain applications, and that otherapplications may require thermoforming to provide an angle of 10, 20,30, 40, 50 or 60 degrees as previously described. Thus, the angle ofinclination may be formed as desired for a specific application.

Each of the lower layer, the upper layer and the insert may be formed ofany of the materials described above. For example, the upper and/orlower layers may be formed of any one of polyethylene, polyurethane,nylon, natural and/or synthetic materials, fabrics, cotton or suitablecombinations thereof. In at least some examples, the upper and/or lowerlayer may be formed of a transparent material so that the wound may beinspected without removing the device. Due to the layering of materials,a stepped configuration having three zones, z1,z2,z3 is formed, firstzone z1 having all three layers, second zone z2 having two layers, andthird zone z3 having only the lower layer.

Notably in FIG. 17A, second zone z2 includes a transitioning edge 1009that gradually widens from the first zone z1 to the third zone z3.Specifically, second zone z2 may include both the lower layer 1006 andthe upper layer 1008 so that the two layers extend along thetransitioning edge 1009. In at least some other examples, insert 1005also extends, partially or fully along, transitioning edge 1009.

As shown in FIG. 17C, hemi-bridge devices 1000 may be used to closelarge wounds W17, similar to the devices previously described. In thisexample, wound W17 may have missing underlying tissue such that piercingand traversing the underlying tissue is difficult or impossible. In sucha case, a suspended suture S17 may be used to gather tissue withouttraversing the underlying tissue through eyelets 1020. In one example,skin may be missing below zone z1 of the device, but may be present inzones z2 and z3. In such a situation, a suture may not pierce the skinadjacent first zone z1, but the hemi-bridge devices 1000 may remainsecured to the skin via zones z2 and z3 only. The gradual widening(e.g., linear or non-linear increase of the width) along transitioningedge 1009 may reduce the risk of tearing in the second zone or failureof the device and may allow for elongation of the device under hightension.

FIGS. 17D-E are schematic top and side views of another embodiment of ahemi-bridge. Hemi-bridge 1000D is similar to hemi-bridge 1000 of FIG.17A, but has slightly different proportions. Generally, hemi-bridge1000D includes a lower layer 1006, an upper layer 1008 and an insert1005 disposed between lower layer 1006 and upper layer 1008. Theproportions and dimensions of one possible hemi-bridge are providedherein, but it will be understood that the hemi-bridge may be scaled upor down as desired. For example, the hemi-bridge may be scaled down to⅕, ¼, ⅓, ½, or ⅔ of the dimensions disclosed. Alternatively, thehemi-bridge may be scaled up to be 1.5×, 2×, 2.5×, 3× or 4× larger thanthe disclosed dimensions.

In the example shown, the total length, LTotal, of hemi-bridge 1000D maybe approximately 80 mm, and the total width, WTotal may be about 30 mm.L1 may be about 35 mm, and each of L2, L3, L4 may be about 15 mm. Thehemi-bridge may be symmetric about the longitudinal axis so that W1 andW3 are equal and about 10 mm each. In this example, W2 is also about 10mm so that the insert is approximately 10 mm in width by 15 mm inlength. The lower layer may be thicker than the upper layer or viceversa, and the insert may be thicker than either the upper or lowerlayers, or both layers combined. In some examples, the lower layer has athickness between 1 mil and 20 mil and the upper layer has a thicknessbetween 1 mil and 20 mil. The insert may have a thickness of between 5mil and 100 mil. In this example, the transition angle β of thetransitioning edge is approximately 30 degrees, although it will beunderstood that the transitioning edge may form a steeper or shallowerangle as desired by varying the length L3. In at least some examples,the transition angle β is less than 45 degrees.

Optionally, a reinforcement 1011 may be disposed in certain sections(e.g., adjacent the transitioning edge) to prevent tearing of thehemi-bridge. As shown in FIG. 17F, hemi-bridge 1000F is shown that has areinforcement layer 1011 disposed on top of upper layer 1008 and atleast partially covering the upper layer 1008. Alternatively,reinforcement layer 1011 may be tucked beneath the upper layer 1008 asshown in FIG. 17G. In both cases, the reinforcement layer 1011 is shownas being shorter than the upper layer 1008, although it is understoodthat the upper layer and the reinforcement layer may be of a same lengthor coterminous. Reinforcement layer 1011 may be of a same material asthe upper layer or the lower layer, or both. For example, in oneembodiment all of upper layers 1008, lower layer 1006 and reinforcementlayer 1011 may be formed of polyurethane.

FIGS. 18A-C are schematic side and top views of other embodiments of ahemi-bridge having waterproof coverings. As previously described,hemi-bridge 1100 extends between proximal and distal ends 1102,1104 andincludes a planar insert 1105 that is covered by lower layer 1106 andupper layer 1108. It will be understood that in manufacturing thedevice, upper and lower layers of material may sandwich an insert andform a configuration similar to the flat configuration previouslydiscussed. In these examples, additional upper and lower coverings 1112a,1112 b formed of waterproof materials that envelope all surfaces andedges of the enclosed bridge assembly. FIG. 18B shows the covering 1112.It will be understood that the upper and lower coverings 1112 a, 1112 bmay be of the same shape and/or size, and may be conterminous with oneanother. As shown, the coverings 1112 may have a footprint that isslightly larger than all of the lower layer, upper layer, and insert sothat an enclosing border 1113 a is formed all around the assembly. Thisenclosing border may extend between 1/16 and ¼ inches farther out fromthe assembly. Additionally, it will be understood that the upper andlower coverings 1112 a, 1112 b may be coupled (e.g., joined, adhered,secured, ultrasonically welded, melted, etc.) together at the enclosingborder to envelop the assembly. FIG. 18C illustrates an embodiment inwhich the hemi-bridge of FIG. 17A is enveloped with upper and lowercoverings and a border 1113 b is formed. Thus, any of the embodimentsdescribed herein may be fully covered or enveloped in this manner.Additionally, an adhesive may be disposed on the bottom of the device insecond and/or third zones z2,z3 to allow the device to be coupleable topatient tissue. In at least some examples, instead of adding discretewaterproofing layers that create an envelope, a spray-on material may beapplied to all or some surface of the bridge to waterproof it. This mayinclude, for example, avocado oils, plant or animal-derived oils,beeswax, silicone, resins and suitable combinations thereof.

FIGS. 19A-D are schematic top views of several examples of eyeletarrangements on a hemi-bridge. Each of the eyelet arrangements describedherein may be combined with any of the bridge configurations describedin this disclosure. In FIG. 19A, a hemi-bridge 1200A includes an inserthaving a single eyelet 1220 a centered vertically and horizontallywithin the insert. In FIG. 19B, a hemi-bridge 1200B includes an inserthaving eyelets 1220 b arranged in a row of multiple eyelets (e.g., two,three or more eyelets) along the longitudinal axis of the device. InFIG. 19C, a hemi-bridge 1200C includes an insert having eyelets 1220 carranged in a column of multiple eyelets (e.g., two, three or moreeyelets) arranged on a line perpendicular to the longitudinal axis ofthe device. In FIG. 19D, a hemi-bridge 1200D includes an insert havingeyelets 1220 d arranged in at least one row and at least one column ofeyelets (e.g., two, three or more eyelets in each row and/or column).

FIG. 20A is a schematic top view of another embodiment of a hemi-bridgehaving a plurality of distinct digits. As shown, bridge 1300 may extendbetween proximal end 1302 and distal end 1304 and have three zones z1-z3including an upper layer, a lower layer and one or more inserts aspreviously described. In this embodiment, bridge 1300 may include aplurality of digits 1310 a, 1310 b, 1310 c (e.g., three digits) in firstzone z1, each of the digits having an insert 1305 sandwiched betweenupper and lower layers 1308,1306. Each of the digits 1310 a-c mayinclude one or more eyelets 1320 defined therein. In second zone z2, anupper layer and a lower layer may be coupled together. In third zone z3,only a lower layer 1306 is present. As shown, third zone z3 includes thelower layer being divided into a plurality of tabs 1330 a-c. As shown,three parallel tabs 1330 a, 1330 c are formed, each tab being alignedwith one of the digits. In this example, the first and third tabs 1330a,c are of a same length, and second tab 1330 b is longer than each ofthem. Alternatively, it will be understood that all three tabs 1330 a-cmay be formed of a same length. Without being bound by any particulartheory, it is believed that by having distinct digits and/or tabs,movement of the patient's skin at one location will not translate toother locations and that the device may be better adhered and moresecurely close the wound.

FIG. 20B is a schematic top view of a hemi-bridge having a plurality ofdigits. As shown, bridge 1400 may extend between proximal end 1402 anddistal end 1404 and have three zones z1-z3 including an upper layer, alower layer and one or more inserts as previously described. Bridge 1400is substantially similar to bridge 1300 except that it includes two tabs1430 a, 1430 b instead of three tabs at the distal end. The two tabs1430 a, 1430 b are generally symmetrical about the central axis of thebridge, and include a cutout 1431 or concavity therebetween. In a thirdembodiment, shown in FIG. 20C, bridge 1500 has a number of digits 1510adjacent proximal end 1502, but only a single curved tab 1530 adjacentdistal end 1504.

As shown in FIG. 20D-E, bridges 1300 may be used to close large woundsW18. In this case, two bridges 1300 are disposed on opposite sides ofthe wound with their digits facing and aligned with one another. Asuture S18 including three loops may be used to gather tissue to closethe wound (FIG. 20E). Other suture patterns are also possible. Forexample, a suture pattern S18′ having a single continuous thread may beused as shown in FIG. 20F.

Instead of having two separate bridges disposed on either side of thewound, a unibody bridge 1600 may be formed having five zones z1-z5.FIGS. 21A-B illustrate one such embodiment in which a bridge 1600extends between first end 1602 and second end 1604. Bridge 1600 mayinclude a plurality of digits 1610 on each of the two ends at zonesz1,z5, each of the digits having the three layers previously described(i.e., lower layer, insert, upper layer). A transitioning section 1615having only the upper and lower layers may be disposed adjacent thedigits in zones z2,z4. An elongated body 1630 composed of only the lowerlayer (or the upper and the lower layer) stretching across all fivezones may extend between the two transition sections. The length and/orwidth of the elongated body 1630 may be varied as desired. In use,unibody bridge 1600 may be wrapped around a body part (e.g., arm,shoulder, knee, or some other body part or joint) so that the two endsare disposed on opposite sides of a wound W19 and the digits on eitherside of the bridge are coupled together via a suture (FIG. 21B).

In at least some embodiments, hemi-bridges may have features, such asopenings, to allow for the passage of air and/or liquid therethrough.For example, FIG. 22A is a schematic top view of one example of ahemi-bridge 1700A having openings in the form of slits 1751 a thatextend parallel to the longitudinal axis of the device. Slits 1751 a arearranged in rows as shown, and each row may include one or more slits.In at least some examples, the slits are offset in adjacent rows.Alternatively, a hemi-bridge 1700B may include slits 1751 b that areperpendicular to the longitudinal axis of the device (i.e., parallel tothe wound edge) and arranged columns, each column having one or moreslits. Instead of slits, a hemi-bridge 1700C may include circularapertures 1751 c arranged in rows and/or columns. Any of these features(or combinations of them) may be disposed in one of the zones (e.g.,limited to one or more locations in the second zone) or in multiplezones (e.g., the second and third zones). Features such as slits oropenings in the second zone may allow air to flow therethrough and allowmoisture to escape the wound to prevent or reduce the possibility ofmaceration. It will be understood that these features may be includedand combined with any of the embodiments described herein.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

It will be appreciated that the various dependent claims and thefeatures set forth therein can be combined in different ways thanpresented in the initial claims. It will also be appreciated that thefeatures described in connection with individual embodiments may beshared with others of the described embodiments.

1. A method of closing a wound, comprising: providing a first bridgingportion comprising a first insert having at least one first eyelet, anda first upper layer of material at least partially disposed over thefirst insert, and a first lower layer of material disposed below thefirst insert, the first lower layer of material having an adhesivedisposed on a first lower surface, wherein the first insert, the firstupper layer and the first lower layer form three zones of differentelasticity and stiffness than others of the zones.
 2. The method ofclaim 1, further comprising the step of: providing a second bridgingportion comprising a second insert having at least one second eyelet,and a second upper layer of material at least partially disposed overthe second insert, and a second lower layer of material disposed belowthe second insert, the second lower layer of material having an adhesivedisposed on a second lower surface, wherein the second insert, thesecond upper layer and the second lower layer form three zones ofdifferent elasticity and stiffness than others of the zones.
 3. Themethod of claim 2, further comprising the step of placing the firstbridging portion and the second bridging portion on opposing ends of awound.
 4. The method of claim 3, wherein placing the first bridgingportion and the second bridging portion on opposing ends of a woundcomprises aligning the first bridging portion and the second bridgingportion parallel with one another.
 5. The method of claim 3, whereinplacing the first bridging portion and the second bridging portion onopposing ends of a wound comprises aligning the first bridging portionand the second bridging portion in line with one another.
 6. The methodof claim 3, wherein placing the first bridging portion and the secondbridging portion on opposing ends of a wound comprises placing the firstbridging portion and the second bridging portion with the first insertbeing closest to the second insert.
 7. The method of claim 3, furthercomprising the step of passing a suture through the first bridgingportion and the second bridging portion.
 8. The method of claim 7,wherein the step of passing a suture through the first bridging portionand the second bridging portion comprises passing the suture through theat least one first eyelet of the first bridging portion and the at leastone second eyelet of the second bridging portion.
 9. The method of claim7, further comprising the step of binding the first bridging portion andthe second bridging portion together with the suture.
 10. A method ofclosing a wound, comprising: placing a first reinforcement on a firstside of a wound, the first reinforcement comprising a first inserthaving at least one first eyelet, and a first upper layer of material atleast partially disposed over the first insert, and a first lower layerof material disposed below the first insert, wherein the first insert,the first upper layer and the first lower layer form three zones ofdifferent elasticity and stiffness than others of the zones; and placinga second reinforcement on a second side of the wound, the secondreinforcement comprising a second insert having at least one secondeyelet, and a second upper layer of material at least partially disposedover the second insert, and a second lower layer of material disposedbelow the second insert, the second lower layer of material having anadhesive disposed on a second lower surface, wherein the second insert,the second upper layer and the second lower layer form three zones ofdifferent elasticity and stiffness than others of the zones; and passinga suture through the first reinforcement and the second reinforcement.11. The method of claim 10, wherein the step of passing a suture throughthe first reinforcement and the second reinforcement includes passingthe suture through the at least one first eyelet of the firstreinforcement and the at least one second eyelet of the secondreinforcement.
 12. The method of claim 10, further comprising the stepof binding the first reinforcement and the second reinforcement togetherwith the suture.